Bisoprolol

Product NDC
52817-270
11-digit product format
528170270
Labeler code
52817
Product ID
52817-270_2a9e4180-cb1c-f924-e063-6394a90a60c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bisoprolol fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
TruPharma, LLC
Application
ANDA075474
Marketing category
ANDA
Marketing start
2019-06-20
Substance
BISOPROLOL FUMARATE
Active strength
5 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bisoprolol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISOPROLOL FUMARATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUR59KN573L
Rxcui854901, 854905

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
97e4a60d-917d-ef62-dc8a-bd557b62b708Product name720260129
9b303cd4-3186-2454-5706-3137e8b2dfd2Product name420221110

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52817-270-10Bisoprolol100 in 1 BOTTLETABLET, FILM COATED1005
52817-270-30Bisoprolol30 in 1 BOTTLETABLET, FILM COATED305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52817-270-10EA - Each52817-2701b2e08ff-d2bc-4270-9b87-046c6f3c078812019-08-06
52817-270-30EA - Each52817-270df0694d8-32ce-4993-b682-1413094fe7bf12019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52817-270BISOPROLOL (BISOPROLOL FUMARATE) TABLET, FILM COATED [TRUPHARMA, LLC]5Current NDC, Legacy NDC, 2 package rows20250102_bba0bc2b-602f-4df1-a761-85bd3c80c7de.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854905bisoprolol fumarate 5 MG Oral TabletPSN78056d0b-2265-4da3-a4fe-b96d98289848100
854905bisoprolol fumarate 5 MG Oral TabletSCD78056d0b-2265-4da3-a4fe-b96d98289848100
854901bisoprolol fumarate 10 MG Oral TabletPSNbba0bc2b-602f-4df1-a761-85bd3c80c7de5
854905bisoprolol fumarate 5 MG Oral TabletPSNbba0bc2b-602f-4df1-a761-85bd3c80c7de5
854901bisoprolol fumarate 10 MG Oral TabletSCDbba0bc2b-602f-4df1-a761-85bd3c80c7de5
854905bisoprolol fumarate 5 MG Oral TabletSCDbba0bc2b-602f-4df1-a761-85bd3c80c7de5
854905bisoprolol fumarate 5 MG Oral TabletPSN91d114ce-5551-455e-82df-d058eb222ac13
854905bisoprolol fumarate 5 MG Oral TabletSCD91d114ce-5551-455e-82df-d058eb222ac13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52817-270-1052817027010100 TABLET, FILM COATED in 1 BOTTLE (52817-270-10) 2019-06-200000-00-00NoNoCurrent
52817-270-305281702703030 TABLET, FILM COATED in 1 BOTTLE (52817-270-30) 2019-06-200000-00-00NoNoCurrent